Structure-Data File Format (SD)
Since 1st October 2022, applicants may now submit chemical structures as a single Structure-Data File format.
Are you holding a dossier in US? If the answer is YES, this brochure may be of your interest!
The context of the US is marked by a higher freedom in establishing pharmaceutical prices what, together with the existence of some of the biggest pharma companies, continues placing the US as one of the biggest shareholders of the market. Hence, the interest in commercializing in the US is notorious for those clients wishing to boost their possibilities.
Nonetheless, the US counts with a rigid regulatory system headed by the FDA, together with CDER and CBER and the Code of Federal Regulations, among others. For a market strategy to be successful within the US context, a good and detailed understanding on how processes and standards vary, as well as having presence and contact with the regulatory authorities becomes paramount when looking for an expansion from the European market.
Our experience in the US aims at positioning your product in a valuable place to foster approval and commercialization.
The context of the US is marked by a higher freedom in establishing pharmaceutical prices what, together with the existence of some of the biggest pharma companies, continues placing the US as one of the biggest shareholders of the market. Hence, the interest in commercializing in the US is notorious for those clients wishing to boost their possibilities.
Nonetheless, the US counts with a rigid regulatory system headed by the FDA, together with CDER and CBER and the Code of Federal Regulations, among others. For a market strategy to be successful within the US context, a good and detailed understanding on how processes and standards vary, as well as having presence and contact with the regulatory authorities becomes paramount when looking for an expansion from the European market.
Our experience in the US aims at positioning your product in a valuable place to foster approval and commercialization.
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Why Asphalion?
Asphalion has been working in Regulatory activities with the FDA since 2005 and has established a strategic alliance with Reguliance, a company founded by Bruce Thompson specialized in providing regulatory support and project management to drug and biotech firms.
For the last 3 years, ASPHALION has managed over 70 projects involving the preparation, submission and/or maintenance of different types of applications for US, including Pre-IND meetings, INDs, NDAs, BLAs, ANDAs, DMFs, ODD and PSPs, in direct contact with the FDA.
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Related Resources
Since 1st October 2022, applicants may now submit chemical structures as a single Structure-Data File format.
Are you holding a dossier in US? If the answer is YES, this brochure may be of your interest!
IND preparation and submission business case: A small European biotech company focused on drug discovery and development interested in engaging with the FDA.
A guide to have an overview of regional submissions requirements
Scientific & Regulatory Affairs Support during development of ATMPs & Biologics
Beginning 15th September 2021
, FDA will enforce the
TechnicalRejection Criteria (TRC)
for Study Data by
CDER
and
CBER
.
This white paper examines the business drivers behind this shift and three factors that are critical to maximizing thebenefits of a unified RIM solution.
A lot of things have happened at Asphalion during these past three months, and we have summarized the highlights in a two minutes video. You can watch it HERE: Hope
The US Food and Drug Administration (FDA) has released an updated preliminary advisory document aimed at assisting sponsors in comprehending the various categories of meetings they can seek to address
Asphalion’s directory provides a comprehensive guide to these bodies around the world.
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Memberships & Partnerships
Quality Management System
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